MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SYRINGE LUER-LOK¿ TIP; PISTON SYRINGE

Catalog Number 301029

Device Problems Break (1069); Volume Accuracy Problem (1675); Defective Device (2588)

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

Event Date 12/21/2021

Event Type  malfunction  

Manufacturer Narrative

Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 0071629, medical device expiration date: 02/28/2025, device manufacture date: 03/19/2020.Medical device lot #: 1005797, medical device expiration date: 12/31/2025, device manufacture date: 01/20/2021.Medical device lot #: 1005805, medical device expiration date: 12/31/2025, device manufacture date: 01/24/2021.Medical device lot #: the customer provided lot # 0240776.This does not match the catalog number provided.Medical device expiration date: unknown, device manufacture date: unknown.Medical device lot #: the customer provided lot #1036006.This does not match the catalog number provided.Medical device expiration date: unknown, device manufacture date: unknown.Medical device lot #: 0071629, medical device expiration date: 02/28/2025, device manufacture date: 03/19/2020.Medical device lot #: 0142212, medical device expiration date: 04/30/2025, device manufacture date: 05/28/2020.Medical device lot #: 0127987, medical device expiration date: 04/30/2025, device manufacture date: 03/13/2020.Medical device lot #: 0142212, medical device expiration date: 04/30/2025, device manufacture date: 05/28/2020.Medical device lot #: 1152292, medical device expiration date: 05/31/2026, device manufacture date: unknown.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 multiple defects were found from a collection of bd syringe luer-lok¿ tips.Defects include barrel/flange damage (9 occurrences), missing scale markings (2 occurrences), illegible/blurred scale markings (26 occurrences), scale markings permanency (13 occurrences), and plunger rod damage (5 occurrences).There was no patient impact.The following information was provided by the initial reporter, translated from (b)(6) to english: "it is impossible to determine how many syringes come from the particular batch#.6 syringes with deformation, 2 unprinted, 10 syringes incomplete/no plunger - lot: 0071629/1005797/1005805; 12 syringes bad print, 6 syringes ink splatter, 1 syringe contamination top.- lot: 0240776/1036006; 1 syringe bad print, 7 syringes ink splashes, 3 bad plunger - lot: 0071629-0142212-0127987; 13 syringes bad print, 1 without rubber, 3 broken, 2 with plunger crooked, 3 contaminated/ink - lot: 0142212/1152292.".

Manufacturer Narrative

H6: investigation summary: fifty-one loose 10ml syringes were received (p/n 301029).Through visual inspection, multiple defects embedded foreign matter, missing plunger rod, distorted stopper, damaged barrel, damaged plunger rod, missing stopper and scale marking defects were observed.Potential root cause for the embedded foreign matter defect is associated with the molding process.The embedded foreign matter is most likely degraded plastic.This occurs when the resin is exposed to prolonged high temperatures inside the molding machine, such as during start up.Potential root cause for the missing plunger rod, distorted stopper, damaged barrel near flange, damaged plunger rod, and missing stopper defect are all associated with the assembly process.Potential root cause for the scale marking defects and barrel damage on samples with scale marking issues is associated with the marking process.These conditions are occurring at/below their expected frequency.Therefore, no corrective action is required at this time.Batches 0071629, 0127987, 0142212, 1005797, 1005805, and 1152292 are considered in compliance with our product specification requirements.A device history record review showed no rejected inspections or quality issues during the production of the provided lot numbers that could have contributed to the reported defect.

Event Description

It was reported that multiple defects were found from a collection of bd syringe luer-lok¿ tips.Defects include barrel/flange damage (9 occurrences), missing scale markings (2 occurrences), illegible/blurred scale markings (26 occurrences), scale markings permanency (13 occurrences), and plunger rod damage (5 occurrences).There was no patient impact.The following information was provided by the initial reporter, translated from dutch to english: "it is impossible to determine how many syringes come from the particular batch #.6 syringes with deformation, 2 unprinted, 10 syringes incomplete/no plunger - lot: 0071629/1005797/1005805.12 syringes bad print, 6 syringes ink splatter, 1 syringe contamination top.- lot: 0240776/1036006.1 syringe bad print, 7 syringes ink splashes, 3 bad plunger - lot: 0071629-0142212-0127987.13 syringes bad print, 1 without rubber, 3 broken, 2 with plunger crooked, 3 contaminated/ink - lot: 0142212/1152292.".

• Brand Name: BD SYRINGE LUER-LOK¿ TIP
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer (Section G): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13256179
• MDR Text Key: 283819058
• Report Number: 1213809-2021-00862
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K980987
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 301029
• Device Lot Number: SEE H.10.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/10/2022
• 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