MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PLASTIPAK¿ SYRINGE; PISTON SYRINGE

Catalog Number 300865

Device Problems Misconnection (1399); Defective Component (2292)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/18/2022

Event Type  malfunction  

Event Description

It was reported that the bd plastipak¿ syringe experienced a bd plastipak¿ syringe experienced damage to the device tip.The following information was provided by the initial reporter: hospital pharmacy workers in the chemotherapy preparation unit using plastipak syringes during the preparation of medicines noted defective screw thread (turns in a vacuum or difficulty in screwing onto another device: spike or tubing).No leakage noted.

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 2204097.Medical device expiration date: 31-mar-2027.Device manufacture date: 19-apr-2022.Medical device lot #: 2204027.Medical device expiration date: 31-mar-2027.Device manufacture date: 01-apr-2022.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the bd plastipak¿ syringe experienced a bd plastipak¿ syringe experienced damage to the device tip.The following information was provided by the initial reporter: hospital pharmacy workers in the chemotherapy preparation unit using plastipak syringes during the preparation of medicines noted defective screw thread (turns in a vacuum or difficulty in screwing onto another device: spike or tubing).No leakage noted.

Manufacturer Narrative

The following fields were updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 23-aug-2022.H.6.Investigation summary: one sample was provided to our quality team for investigation.The product was visually inspected, no damage or molding defects were observed, the tips were properly molded, and no defects were identified in the tip or luer threading.A device history review was performed for the reported lots 2204027 and 2204097, no deviations or non-conformances were identified during the manufacturing process that could have contributed to the reported issue.Final products in this manufacturing line, for this reference are sampled and they are subjected to visual and functional inspections during the different manufacturing sub-processes according to procedure, including tip and thread verification, no issues related to the reported incident were found.The returned sample underwent these same evaluations and no issues were identified, product was verified to meet required specifications.It is possible the luer was damaged due to overscrewing when engaging the device, however, based on the sample evaluation, this cannot be verified.Based on the available information, we cannot identify definitive root cause at this time.Complaints received for this device and reported condition will be monitored by our quality team for signs of emerging trends.H3 other text : see h10.

• Brand Name: BD PLASTIPAK¿ SYRINGE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• Manufacturer (Section G): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15214822
• MDR Text Key: 303058056
• Report Number: 3003152976-2022-00366
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 300865
• Device Lot Number: SEE H10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1