MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD INTEGRA SYRINGE WITH DETACHABLE NEEDLE; PISTON SYRINGE

Model Number 305270

Device Problems Break (1069); Difficult or Delayed Activation (2577)

Patient Problems Blood Loss (2597); Device Embedded In Tissue or Plaque (3165)

Event Date 03/16/2020

Event Type  Injury  

Manufacturer Narrative

Medical device expiration date: unknown.The customer's address is unknown.Unknown, (b)(6) usa has been used as a default.Device manufacture date: unknown.Investigation summary: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.The lot number is unknown, therefore device history record review (dhr) or quality notification review (qn) could not be performed.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.Investigation conclusion: unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure as no samples or photos were returned.Root cause description: no root cause can be determined as no samples were received.Rationale: capa is not necessary at this time.

Event Description

It was reported that the bd integra¿ syringe's detachable needle broke off while injecting testosterone.Blood "came squirting out" of the patient when the needle was inserted, "shooting about a foot away".The broken needle remained in the consumer, who visited the er as a result and had a sonogram performed.The er was unable to remove the needle, and the consumer was referred to a specialist.An operation under anesthesia was performed, and the needle was removed successfully.The following information was provided by the initial reporter: "i received a phone call this morning from a direct consumer regarding product 305270.Customer stated that the needle did not retract and is now stuck in him.He stated that he went to the er and they could not remove it and referred him to a specialist.The specialist told him he will need to do day surgery in order to get it out, and that it will cost (b)(6)." "on tuesday i was at home giving myself a shot of testosterone using 3ml 25g x 1 extractor needle lot #dg177206, as we have been doing for the last 3 plus years.Unlike the other 80-100 times i have done this, when the needle was inserted, something went wrong and blood came squirting out of me shooting about a foot away." i could not find the needle or see it in the syringe, so we went to the emergency to have it taken out.They told me they could see it using sonogram, but could not remove it, so referred me to a specialist.They told me that removing it would require an operating room, complete with anesthesiologist who would put me under.And that is what was done.

Event Description

It was reported that the bd integra¿ syringe's detachable needle broke off while injecting testosterone.Blood "came squirting out" of the patient when the needle was inserted, "shooting about a foot away".The broken needle remained in the consumer, who visited the er as a result and had a sonogram performed.The er was unable to remove the needle, and the consumer was referred to a specialist.An operation under anesthesia was performed, and the needle was removed successfully.The following information was provided by the initial reporter: "i received a phone call this morning from a direct consumer regarding product 305270.Customer stated that the needle did not retract and is now stuck in him.He stated that he went to the er and they could not remove it and referred him to a specialist.The specialist told him he will need to do day surgery in order to get it out, and that it will cost $22,000." "on tuesday i was at home giving myself a shot of testosterone using3ml 25g x 1 extractor needle lot #dg177206, as we have been doing for the last 3 plus years.Unlike the other 80-100 times i have done this, when the needle was inserted, something went wrong and blood came squirting out of me shooting about a foot away." i could not find the needle or see it in the syringe, so we went to the emergency to have it taken out.They told me they could see it using sonogram, but could not remove it, so referred me to a specialist.They told me that removing it would require an operating room, complete with anesthesiologist who would put me under.And that is what was done.

Manufacturer Narrative

The following fields were updated due to additional information: d.10 device available for eval yes, returned to manufacturer on: 2020-05-29.H.6.Investigation summary two 3ml integra syringes were received.One syringe was in a fully sealed blister pack with much of the batch # erased and illegible, p/n 305270.One syringe was a used sample loose inside a separate small zip lock bag.The syringes were reportedly decontaminated prior to arrival.However, some unidentified liquid material remained and was observed in the loose syringe.The loose syringe contained residue inside and outside the fluid path and all scale markings were observed to have been removed.The syringe in the blister pack was taken out and visually inspected.The plunger rod was depressed, and the retraction mechanism was activated.It appeared to function as expected with the cannula retracting and becoming concealed inside the plunger rod.The loose syringe was removed from the zip lock bag and visually inspected on the examination tabletop.It was observed the retraction mechanism had been activated as the metal cutter was pierced through the stopper and the spring was exposed.Part of the spring was observed to be in the hub and the rest wrapped around the cutter.The syringe was oriented with the tip facing downward.It was then carefully tapped several times and the cannula gradually slid out from inside the plunger rod.In both syringes received the retraction mechanism appeared to have functioned as expected by retracting the cannula into the inner plunger rod where it was contained.In the used sample it is unknown why the spring was exposed, and the plunger rod was not fully bottomed out.However, this can happen if the sample is manipulated after the retraction activation by pulling back on the plunger rod until the spring is loose, then, depressing the plunger rod back to the position.Since the cannula retracted and was found intact inside the inner plunger rod, no defects could be confirmed at this time.The lot number is unknown, therefore device history record review (dhr) or quality notification review (qn) could not be performed.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.

• Brand Name: BD INTEGRA SYRINGE WITH DETACHABLE NEEDLE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 9901306
• MDR Text Key: 196470853
• Report Number: 1213809-2020-00220
• Device Sequence Number: 1
• Product Code: MEG
• UDI-Device Identifier: 30382903052708
• UDI-Public: 30382903052708
• Combination Product (y/n): N
• PMA/PMN Number: K011103
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 06/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 305270
• Device Catalogue Number: 305270
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2020
• Date Manufacturer Received: 03/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention