MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD¿ CATHETER TIP SYRINGE; IRRIGATING SYRINGE

Catalog Number 309620

Device Problems Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944); Protective Measures Problem (3015)

Patient Problems Exposure to Body Fluids (1745); Foreign Body In Patient (2687)

Event Date 05/24/2019

Event Type  malfunction  

Manufacturer Narrative

There are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.(b)(4).Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: bd was unable to perform a thorough investigation as no sample, lot, or batch number were provided.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: bd was not able to duplicate or confirm the customer¿s indicated failure as no sample, batch, or lot code was provided.This complaint will be entered into the complaint management system and will be tracked & trended for future occurrences.Root cause description: root cause is undetermined.Rationale: no sample, lot, or batch provided.

Event Description

Part no.: unknown.Batch/lot: unknown.It was reported that during use of the unspecified bd¿ syringe 60cc there was a "retained foreign object, which was a syringe cap used to instill a testing medium.The syringe was recapped by a technician after filling it with the medium and left on the procedure table for the rn.When the rn instilled the medium she did not realize that the syringe cap was still on and injected the cap into the body cavity which was later found on mri".The medium procedure was being done in preparation for the mri the mri was not performed to find the cap.However the cap was found as the scheduled mri was done.A voicemail indicated that "there was no patient and no surgical removal or intervention needed".The following information was provided by the initial reporter: we recently had a retained foreign object, which was a syringe cap used to instill a testing medium.The syringe was recapped by a technician after filling it with the medium and left on the procedure table for the rn.When the rn instilled the medium she did not realize that the syringe cap was still on and injected the cap into the body cavity which was later found on mri.I had other discussions with rns to ascertain how often this happens and surprisingly enough it happens a lot.However, it usually happens during checking of ng tubes and the syringe which is filled with fluid back splashes on the rn due to the cap not being removed.In this particular case however was used to inject into a body cavity which accommodated the cap.

Event Description

Part no.: 309620.Batch/lot: unknown.It was reported that during use of the bd¿ catheter tip syringe there was a "retained foreign object, which was a syringe cap used to instill a testing medium.The syringe was recapped by a technician after filling it with the medium and left on the procedure table for the rn.When the rn instilled the medium she did not realize that the syringe cap was still on and injected the cap into the body cavity which was later found on mri".The medium procedure was being done in preparation for the mri the mri was not performed to find the cap.However the cap was found as the scheduled mri was done.A voicemail indicated that "there was no patient and no surgical removal or intervention needed".The following information was provided by the initial reporter: we recently had a retained foreign object, which was a syringe cap used to instill a testing medium.The syringe was recapped by a technician after filling it with the medium and left on the procedure table for the rn.When the rn instilled the medium she did not realize that the syringe cap was still on and injected the cap into the body cavity which was later found on mri.I had other discussions with rns to ascertain how often this happens and surprisingly enough it happens a lot.However, it usually happens during checking of ng tubes and the syringe which is filled with fluid back splashes on the rn due to the cap not being removed.In this particular case however was used to inject into a body cavity which accommodated the cap.

Manufacturer Narrative

D.1.Medical device brand name: bd¿ catheter tip syringe.D.2.Common device name: irrigating syringe.D.3.Medical device manufacturer: bd medical (bd west) medical surgical.D.4.Medical device catalog #: 990193.D.4.Unique identifier (udi) #: (b)(4).F.1.Device codes 1354, 3015.G.2.Manufacturing location: bd medical (bd west) medical surgical.H3 other text: see section h.10.

• Brand Name: BD¿ CATHETER TIP SYRINGE
• Type of Device: IRRIGATING SYRINGE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 8722384
• MDR Text Key: 149356796
• Report Number: 2243072-2019-01229
• Device Sequence Number: 1
• Product Code: KYZ
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 07/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 309620
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 05/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other